Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K122069 |
Device Name |
STORM MINI SCREW |
Applicant |
LANCER ORTHODONTICS, INC. |
2330 Cousteau Court |
Vista,
CA
92081
|
|
Applicant Contact |
LARRY WALKER |
Correspondent |
LANCER ORTHODONTICS, INC. |
2330 Cousteau Court |
Vista,
CA
92081
|
|
Correspondent Contact |
LARRY WALKER |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 04/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|